NAMSA’s Post

CHAPTER 01: Defining Your PMCF Strategy with Precision Embarking on the journey to meet MDR requirements begins with a well-defined PMCF strategy. At ECLEVAR, we believe in laying a strong foundation before leaping into action. Why is this initial step crucial? Because satisfying your Notified Body and adhering to MDR mandates is contingent upon collecting pertinent data effectively and efficiently. Here's how we approach it: 🤝 Collaborative Evaluation: Working alongside our clients, we assess various elements such as costs, practicality, timelines, and the volume of marketed devices. 🧠 Scientific & Business Insight: Integrating scientific rationale with strategic business decisions to shape your PMCF strategy. 📈 Expert Input: Leveraging insights from our clinical and regulatory teams to craft a comprehensive strategy. ✅ Strategic Alignment: Ensuring the strategy resonates with your objectives and our combined expertise. Don't navigate the complexities of PMCF alone! Discover how ECLEVAR can support your compliance journey and enhance your market success. #PMCF #PMCFStrategy #PMCFPlan #PMCFReport #PMCFStudy #MedicalDevices #MDR #ECLEVAR #CRO

🚀 Case Study Spotlight: Fast-Tracked PMCF Activities 🚀 We are thrilled to share a compelling case study that delves into the successful implementation of fast-tracked Post-Market Clinical Follow-up (PMCF) activities. In the highly regulated area of medical devices, ensuring continuous compliance and product efficacy is paramount. This study highlights how a proactive and accelerated PMCF strategy not only met stringent regulatory requirements but also enhanced patient outcomes and market confidence. By leveraging innovative methodologies and cross-functional collaboration, the project achieved remarkable results in record time. Dive into this case study to uncover the strategies and insights that drove this exceptional achievement: 👉 https://lnkd.in/ebQ_8Bt7 #MedicalDevice #RegulatoryAffairs #PMCF #regulatoryrequirements #medtech #postmarket #clinicalfollowup #MDR #realworlddata #realworldevidence

📈 STEP 2: Crafting Your Medical Device PMCF Plan With a solid PMCF strategy in place, the next pivotal step is to translate that strategy into a concrete PMCF plan. This critical document delineates the specific PMCF activities tailored for your medical device, ensuring ongoing compliance and vigilance. While MDCG 2020-7 offers a template for a PMCF plan, it falls short of guiding you through the nuances of execution or aligning with Notified Body expectations. That's where our expertise comes into play: 📝 Tailored Documentation: Our clinical and regulatory teams, experienced in global PMCF requirements, will develop a comprehensive PMCF plan that details the methodologies for data collection 🔍 Safety and Performance Confirmation: We'll outline procedures to continuously verify your device's safety and performance 🚨 Risk Management: Identifying potential unknown side effects, emergent risks, and instances of off-label use or systematic misuse ⚖️ Benefit-Risk Assessment: Ensuring the benefit-risk ratio remains favorable as per your risk management framework Let us guide you in developing a PMCF plan that not only meets regulatory standards but also supports the continued success of your medical device on the market. Discover how NAMSA can support your compliance journey and enhance your market success. https://lnkd.in/ghEtDuvZ #PMCF #PMCFStrategy #PMCFPlan #PMCFReport #PMCFStudy #MedicalDevices #MDR #NAMSAKnows #CRO

#Didyouknow The FDA has issued a revised #QSubmission guidance, open for comment until April 1t5h. The revised draft guidance is set to provide further clarifications on when an informal communication is more appropriate than a full Q-Submission and provides more details on #PMA Day-100 Meetings. Evnia has long experience with #QSubs and an in-house group of #FDAexperts, who can guide you through the preparation process for a Q-Sub and even join you on your meeting! How can Evnia help? 💡 By developing your set of specific questions to the FDA 💡 By preparing the Pre-Sub documentation and conducting a regulatory gap assessment of your current strategy in terms of non-clinical bench testing protocols, #usability and performance testing and #clinicaldevelopment plans 💡 By compiling the Q-Sub meeting request package 💡 By assisting in the preparation for the meeting and helping you practice for anticipated questions by the FDA. 💡 By participating in the Q-Sub in-person meeting or conference call with the FDA ensuring an effective interpretation of yours and FDA's arguments 😉 #medtech #medicaldevices #fdacompliance

🚀 Exciting News for Medical Device Manufacturers! 🚀 The FDA has just issued the Quality Management System Regulation (QMSR) Final Rule, emphasizing risk management and streamlining compliance for device manufacturers. This regulatory update aims to ensure the safety, effectiveness, and quality of medical devices in the market. 💡 Implications for Manufacturers: Failure to comply can lead to serious consequences, including product recalls and legal penalties. Manufacturers must act now to understand and implement necessary changes to their quality management systems. At NAMSA, our expert team can provide comprehensive support and guidance to ensure compliance. From tailored consulting services to innovative solutions, we are committed to helping our clients meet regulatory requirements while maintaining the highest standards of quality and safety. Let's ensure continued access to safe, effective, and high-quality medical devices for patients and providers worldwide. Contact us today to meet with our Quality experts and learn how NAMSA can help you transition to QSMR 👉 https://lnkd.in/eT4jM3w #FDA #MedicalDevices #RegulatoryCompliance #QMSR #CRO #NAMSAKnows

An inventive Australian MedTech firm specialising in Incision Management sought CLIN-r+'s support to surmount a pivotal regulatory challenge. An audit gave them a major non-conformity that hindered their EU MDR transition and compliance efforts. The root issue was a lack of clinical data due to a missing Post-Market Clinical Follow-up (PMCF) strategy. Despite securing a MDD certificate via equivalence, their Class IIa device faced data gaps. Acknowledging the risk and their unfamiliarity with European post-market clinical studies, the manufacturer turned to CLIN-r+. Our role? To strengthen Post Market Surveillance (PMS) efforts, align with Article 120 requirements for EU MDR extension, and expedite clinical data acquisition. The aim: attain EU MDR readiness for an imminent audit in just six months. This case study underlines our commitment to guiding MedTech innovators toward regulatory triumph and shows you how we did it. https://loom.ly/qfa3O6I #clinicaldata #clinicalstudies #clinicaltrials #medtech #eumdr #casestudy #mdr #transition #strategy #mdd #pmcf #postmarketsurveillance #vigilance #realworlddata #realworldevidence #cemarking #clinicalevaluation #statistics #riskmanagement

Designed to streamline the regulatory processes involved in expanding into multiple markets, the Medical Device Single Audit Program (MDSAP) aims to uphold a uniform standard of device quality and safety across regions. In the following article, we delve into essential insights about MDSAP, crucial for manufacturers contemplating this regulatory route. For more information, click here: https://bit.ly/4bbCDvF #MDSAP #QMS #RegulatoryRequirements

"Can I Include in My PMCF Plan a Third-Party Study That I'm Not a Sponsor?" 🤔 Are you a #Quality & #RegulatoryAffairsEngineer, #ClinicalProjectManager, or #ClinicalEvaluationSpecialist asking yourself this question? You're not alone.   A medical device startup recently posed this question to me. The answer is YES, you can—but there are conditions. Let's dive in.   📜 MDR Annex XIV Gives the Green Light   If you're a manufacturer with access to the results and methodology of a third-party study, MDR Annex XIV allows you to include it in your PMCF activities. This is essential information for those navigating the complex world of medical device regulations.   🎯 Why This Matters to You   Credibility Boost: Including third-party studies can enhance the trustworthiness of your PMCF Plan.   Richer Data Pool: Diverse data sources can improve your medical device evaluation, a crucial factor in achieving regulatory compliance.   Efficiency: Leveraging existing studies can save both time and resources, something highly valued by project managers and regulatory affairs engineers.   👇 Your Thoughts?   I'm eager to hear from you. Have you ever included a third-party study in your PMCF Plan? Your insights could be invaluable to the community. Share your experiences below!   #PMCFPlan #MDR #ClinicalEvaluation

The recent FDA ruling on Laboratory Developed Tests (LDTs) marks a significant shift in regulatory oversight within the diagnostics landscape! Traditionally, LDTs, developed and performed within a single laboratory, have been regulated under the Clinical Laboratory Improvement Amendments (CLIA) by CMS, with minimal FDA involvement. However, the FDA's new framework brings certain high-risk LDTs under its purview, aiming to enhance patient safety and test accuracy. Under the FDA's oversight, these high-risk LDTs will undergo premarket review, akin to other diagnostic tests, ensuring they meet rigorous standards for analytical and clinical validity. This move aims to harmonize regulations, providing a level playing field for all test developers while maintaining innovation and patient access. Understanding this ruling is crucial for laboratories, manufacturers, and healthcare providers navigating the evolving regulatory landscape. The FDA intends to hold a webinar on May 14, 2024, to provide an overview of the final rule and phaseout policy.  #FDA #LDTs #Diagnostics #RegulatoryUpdate #PatientSafety #HealthcareRegulation #LinkedInLearning